THERE S MORE TO KNOW Diagnosed with DVT/PE blood clots? Your journey with XARELTO starts here. Do not stop taking XARELTO without talking to your doctor. Stopping XARELTO increases your risk of having a DVT or PE blood clot. Please see accompanying full Prescribing Information for XARELTO, including Boxed Warnings, and Medication Guide, and Important Safety Information.
2 Welcome You were diagnosed with a DVT or PE. Now you ask yourself: What s next? You wonder if it could happen again, and what caused it in the first place. But most importantly, you want to understand how you can help protect yourself from another event. As you embark on your treatment and recovery with XARELTO, we want you to know that we have resources to help you start and stay on track. Along with the discussions you ve already had with your healthcare provider, we want to give you information and tools to move ahead. Let s get started. XARELTO can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that reduces blood clotting. While you take XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. Call your doctor or get medical help right away if you develop any signs or symptoms of bleeding.
4 What are DVT and PE blood clots?? A deep vein thrombosis (DVT) is a blood clot that forms in a vein deep inside your body, such as in the legs. DVT is a serious condition and can lead to a pulmonary embolism. Did you know that DVT and PE cause more deaths in the US than breast cancer, traffic accidents, and HIV combined? DVT PE DVT/PE 100,000 A pulmonary embolism (PE) occurs when a blood clot formed elsewhere in your body travels through the bloodstream and becomes lodged in your lungs. A PE can block blood flow and is potentially life threatening. Breast Cancer, Traffic Accidents, and HIV 82,840 A PE and a DVT are collectively referred to as VTE (venous thromboembolism). Do not take XARELTO if you: Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO.
6 What are the risk factors? Though it is not always possible to pinpoint the exact reason you had a DVT or PE, there are risk factors that contribute to their onset. They include: Sitting in a car or plane for a long time Being overweight Undergoing treatment for cancer Being over 60 years of age Smoking A family history of DVT or PE Having a recent injury or surgery Taking birth control pills or hormone therapy Pregnancy, especially the first 6 weeks after giving birth Do not stop taking XARELTO without talking to your doctor. Stopping XARELTO increases your risk of having a DVT or PE blood clot.
8 What are the symptoms? Common symptoms of a DVT include: Swelling of the leg or affected area Pain or tenderness at rest or when standing or walking Skin that is warm to the touch Skin that is red or discolored Why XARELTO may be right for you If you ve already had a DVT or PE, you have an increased risk of developing another blood clot, and your risk increases over time. However, it s important to note that as many as half of the people who get a DVT show no symptoms. Risk of another DVT or PE after stopping treament* If caused by: After 1 year After 5 years A recent surgery (eg, hip or knee) 1% 3% Common symptoms of a PE include: A nonsurgical event (eg, pregnancy, leg injury, long flights) 5% 15% Unexplained shortness of breath Rapid breathing Chest pain under rib cage that may worsen with deep breath Coughing or coughing up blood XARELTO can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that reduces blood clotting. While you take XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. Unknown risk factor 10% 30% *In patients with upper-leg DVT or PE after stopping treatment with a blood thinner. Your individual risk may vary, so talk to your doctor. Treatment with XARELTO reduces your risk of another DVT or PE blood clot. It s been proven to have similar effectiveness to warfarin, with significantly less major bleeding. XARELTO works by helping to prevent the formation of blood clots.
10 How do blood thinners work? Despite their name, blood thinners do not actually thin the blood. See how XARELTO compares to warfarin XARELTO (rivaroxaban) Warfarin (eg, Coumadin )* They work by reducing the formation of blood clots in your arteries or veins. While blood thinners do not dissolve existing clots, they can help prevent clots from becoming larger and causing more serious problems. How Medication Works XARELTO works by blocking Factor Xa ( 10a ), an enzyme needed for blood clots to form. Warfarin works by interfering with vitamin K, and at least 6 blood-clotting factors. There are 2 main types of blood thinner medicines: Anticoagulants, such as XARELTO, help prevent or reduce blood clotting Blood Monitoring No regular blood tests. Regular blood tests are not required with XARELTO. Requires blood tests. Blood tests are required at the start and throughout your treatment. Antiplatelet drugs, such as aspirin, help keep platelets (a type of blood cell) from sticking together and forming a clot Learn more about anticoagulation therapy and how it can help people Dietary Restrictions No known dietary restrictions. With XARELTO, you can continue to eat the healthy foods you enjoy. Dietary restrictions exist. Spinach, cabbage, broccoli, and other foods high in vitamin K can affect how well warfarin works. who have had DVT or PE blood clots. Visit and watch videos at: www.goemmi.com/dvtpe Need help? Email: support@emmisolutions.com Or call: 1-866-294-3664 Drug Interactions There are limited known interactions between XARELTO and other medications. Please talk to your doctor about a list of medications that may interact with XARELTO. There is a broad range of medications that interact with warfarin. Please talk to your doctor about a list of medications that may interact with warfarin. *Coumadin is a registered trademark of Bristol-Myers Squibb. Emmi is a registered trademark of Emmi Solutions, LLC. 2013 Emmi Solutions, LLC. Anticoagulant (blood thinner) Medications for DVT program.
12 What is XARELTO? XARELTO is a latest-generation blood thinner that s proven to reduce the risk of another DVT and PE. In clinical studies, almost 98% of people taking XARELTO did not experience another DVT or PE.* *Patients were followed for an average length of treatment of 208 days. To benefit from XARELTO, you should take it exactly as your doctor prescribes. Your doctor will decide how long you should take XARELTO. Do not stop taking XARELTO without talking with your doctor first. Stopping XARELTO may increase your risk of stroke. If you miss a dose of XARELTO, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Tell all your doctors, including dentists, that you are taking XARELTO. They should talk to the doctor who prescribed XARELTO for you before any surgical, medical, or dental procedure. Your doctor may stop your XARELTO for a short time and tell you when to start taking XARELTO again after your surgery or procedure. Start your treatment with XARELTO XARELTO has already been prescribed more than 36 million times in the US, and it is proven to work. In the largest clinical study of DVT and PE ever conducted, XARELTO was proven effective at treating DVT and PE, and reducing the risk of these blood clots happening again. For most patients who are prescribed XARELTO for DVT or PE, the dosing schedule is: Initial treatment of at least 6 months First 21 days Start with: One 15-mg tablet twice a day with food AM Tablets shown not actual size. PM On day 22 Switch to: One 20-mg tablet once a day with food Treatment to reduce the risk of another DVT or PE After at least 6 months Switch to: One 10-mg tablet once a day with or without food Do not take XARELTO if you: Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO.
14 Use this Dosing Diary to help make your treatment easy to follow Start with 1 XARELTO 15-mg tablet twice a day with food. Week 1 starting date: / / Scheduled times: AM PM On day 22, switch to 1 XARELTO 20-mg tablet once a day with food. Week 5 starting date: / / Scheduled times: AM PM Check the box below for the each dose taken every day. day for each week. Check the box below for the dose taken every day. WEEK 3 WEEK 2 WEEK 1 AM PM AM PM AM PM Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Day 12 Day 13 Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20 Day 21 WEEK 5 WEEK 6 WEEK 7 WEEK 8 WEEK 9 WEEK 10 WEEK 11 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Taking all of your medication is important, even if you re feeling well. 15-mg tablet WEEK 12 WEEK 13 On day 22, switch to 1 XARELTO 20-mg tablet once a day with food. Week 4 starting date: / / Scheduled times: AM PM WEEK 14 WEEK 15 Check the box below for the dose taken every day. WEEK 4 Continue to take your medication as prescribed. Do not stop without talking to your healthcare provider. Tablets shown not actual size. Day 22 Day 23 Day 24 Day 25 Day 26 Day 27 Day 28 20-mg tablet Continue to take your medication as prescribed. Do not stop without talking to your healthcare provider. 20-mg tablet You can take your dosing diary with you. Go to page 23 and find a dosing diary that fits in your wallet.
16 Talking with your doctor Keeping an open and honest conversation going with your doctor will help you get the best care. At your next appointment, tell your doctor how you re feeling that day and if you are experiencing any DVT or PE symptoms. Here are some questions you may want to ask: Can I still be physically active with DVT or PE? Can a DVT or PE lead to a heart attack? If I m no longer feeling any symptoms, does that mean I no longer have to worry? How does XARELTO help treat and prevent another DVT or PE? What are the benefits and side effects of XARELTO compared to warfarin? If there are no regular blood tests or known dietary restrictions, how do I know XARELTO is working? Janssen Your Partner for Cost Support At Janssen, we don t want cost to get in the way of treatment you need. We can help you explore options to lower your out-of-pocket cost for XARELTO. Janssen CarePath offers you valuable information and tools to help you better understand your condition, stay with the treatment plan your doctor prescribes, and save on your XARELTO prescription costs. Janssen CarePath Savings Program See your healthcare provider to learn about how you may be eligible to save on your next XARELTO prescription Free Medication Tracker Keep a record of your medications and a reminder of when to take them Ongoing Support Valuable information to learn more about treating your condition or changing your dose, if necessary Helpful Reminders Reminders on when to refill your prescription Care4Today Connect A helpful medication, appointment, and healthy habits reminder tool Dedicated Care Coordinator A live Care Coordinator can review your insurance coverage for XARELTO and help identify options to help you pay for XARELTO Signing up is easy. Go to janssencarepath.com/xarelto or call 1-888-XARELTO (1-888-927-3586). Am I eligible to save on XARELTO through the Janssen CarePath Savings Program?
18 Frequently Asked Questions It is normal to have questions when it comes to your treatment options. You want to make sure you are taking all the steps you can when it comes to protecting your health. Q. What makes XARELTO different? A. Here s why XARELTO is different: warfarin interferes with vitamin K and at least 6 blood-clotting factors. XARELTO is selective, targeting just one critical factor of your body s natural blood-clotting function. With XARELTO, you don t have to plan your schedule around a blood monitoring routine or change the way you eat. Q. Can I afford XARELTO, a branded medication? A. If you have commercial health insurance with prescription coverage, you may be eligible for the Janssen CarePath Savings Program to receive instant savings on your next XARELTO prescription. See your healthcare provider and ask about the Janssen CarePath Savings Program or call 1-888-XARELTO (1-888-927-3586) to enroll or complete activation. Q. What is the most important side effect I should be aware of? A. Like all blood thinners, XARELTO can cause bleeding, which can be serious, and rarely may lead to death. Be sure to take XARELTO exactly as prescribed and do not stop taking XARELTO without talking with your doctor first. Stopping XARELTO may increase your risk of having DVT or PE happen again. You should discuss all potential benefits and risks with your doctor. Third party trademarks used herein are trademarks of their respective owners. Q. Are there any foods or medicines I should avoid when taking XARELTO? A. Unlike warfarin, XARELTO has no known dietary restrictions. You can eat leafy greens without affecting how XARELTO works. Like all blood thinners, you have a higher risk of bleeding if you take XARELTO with other medicines, such as: aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, clopidogrel (Plavix ), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or other medicines to prevent or treat blood clots. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. WHAT IS XARELTO (rivaroxaban)? XARELTO is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO and warfarin compare in reducing the risk of stroke. XARELTO is also a prescription medicine used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months. XARELTO is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
20 IMPORTANT SAFETY INFORMATION WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO? For people taking XARELTO for atrial fibrillation: People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO, you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. XARELTO can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that reduces blood clotting. While you take XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take XARELTO and take other medicines that increase your risk of bleeding, including: Aspirin or aspirin-containing products Non-steroidal anti-inflammatory drugs (NSAIDs) Warfarin sodium (Coumadin, Jantoven ) Any medicine that contains heparin Clopidogrel (Plavix ) Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) Other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding: Unexpected bleeding or bleeding that lasts a long time, such as: Nosebleeds that happen often Unusual bleeding from gums Menstrual bleeding that is heavier than normal, or vaginal bleeding Bleeding that is severe or you cannot control Red, pink, or brown urine Bright red or black stools (looks like tar) Cough up blood or blood clots Vomit blood or your vomit looks like coffee grounds Headaches, feeling dizzy or weak Pain, swelling, or new drainage at wound sites Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine like XARELTO, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: A thin tube called an epidural catheter is placed in your back to give you certain medicine You take NSAIDs or a medicine to prevent blood from clotting You have a history of difficult or repeated epidural or spinal punctures You have a history of problems with your spine or have had surgery on your spine If you take XARELTO and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence). XARELTO is not for people with artificial heart valves. Do not take XARELTO if you: Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO. Before taking XARELTO, tell your doctor about all your medical conditions, including if you: Have ever had bleeding problems Have liver or kidney problems Are pregnant or plan to become pregnant. It is not known if XARELTO will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with XARELTO. Taking XARELTO while you are pregnant may increase the risk of bleeding in you or in your unborn baby. Please see full Prescribing Information, including Boxed Warnings, and Medication Guide, in pocket.
22 IMPORTANT SAFETY INFORMATION (cont d) If you take XARELTO during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See What is the most important information I should know about XARELTO? for signs and symptoms of bleeding. Are breastfeeding or plan to breastfeed. XARELTO may pass into your breast milk. You and your doctor should decide if you will take XARELTO or breastfeed. Tell all of your doctors and dentists that you are taking XARELTO. They should talk to the doctor who prescribed XARELTO for you before you have any surgery, medical or dental procedure. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO works. Certain medicines may increase your risk of bleeding. See What is the most important information I should know about XARELTO? HOW SHOULD I TAKE XARELTO? Take XARELTO exactly as prescribed by your doctor. Do not change your dose or stop taking XARELTO unless your doctor tells you to. Your doctor may change your dose if needed. If you take XARELTO for: Atrial Fibrillation: Take XARELTO 1 time a day with your evening meal. If you miss a dose of XARELTO, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Blood clots in the veins of your legs or lungs: Take XARELTO 1 or 2 times a day as prescribed by your doctor. For the 15-mg and 20-mg doses, XARELTO should be taken with food. For the 10-mg dose, XARELTO may be taken with or without food. Take your XARELTO dose(s) at the same time each day. If you miss a dose: > If you take the 15-mg dose of XARELTO 2 times a day (a total of 30 mg of XARELTO in 1 day): Take XARELTO as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time. > If you take XARELTO 1 time a day: Take XARELTO as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Hip or knee replacement surgery: Take XARELTO 1 time a day with or without food. If you miss a dose of XARELTO, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. If you have difficulty swallowing the XARELTO tablet whole, talk to your doctor about other ways to take XARELTO. Your doctor will decide how long you should take XARELTO. Your doctor may stop XARELTO for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO again after your surgery or procedure. Do not run out of XARELTO. Refill your prescription for XARELTO before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO available to avoid missing any doses. If you take too much XARELTO, go to the nearest hospital emergency room or call your doctor right away. WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO? See What is the most important information I should know about XARELTO? Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800- FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736). Please see full Prescribing Information, including Boxed Warnings, and Medication Guide, in pocket. Trademarks are those of their respective owners. Detach this wallet card and complete both sides to help you remember your dosing schedule. Keep it with you in case of an emergency. XARELTO (rivaroxaban) for DVT or PE (circle one) 15 mg Start date First 21 days Start with: One 15-mg tablet twice a day with food AM PM Tablets shown not actual size. 20 mg Start date On day 22 Switch to: One 20-mg tablet once a day with food 10 mg Start date At 6 months, ask your doctor if you are at continued risk for another DVT/PE and if the 10-mg dose is right for you 083075-171026 DVT = deep vein thrombosis; PE = pulmonary embolism.
We hope this brochure has been helpful in answering your questions and guiding you on your journey with XARELTO. Please feel free to visit us at XARELTO.com or by calling 1-888-XARELTO (1-888-927-3586). Please see accompanying full Prescribing Information for XARELTO, including Boxed Warnings, and Medication Guide, and Important Safety Information. XARELTO is licensed from Bayer HealthCare AG, 51368 Leverkusen, Germany Janssen Pharmaceuticals, Inc. 2018 February 2018 cp-48701v1 Third party trademarks used herein are trademarks of their respective owners. Janssen Pharmaceuticals, Inc.